News & Analysis as of

Pharmaceutical Industry Mensing

Non-Existent Duty to Warn of Mensing Not Enough to Get Around Mensing Preemption

by Reed Smith on

Earlier this week, we discussed how the presentation of the federal question of express preemption from the face of a complaint can lead to removal. Part of why the defendant drug or device manufacturer may prefer federal...more

What If We Win? Off-Label Promotion & Product Liability

by Reed Smith on

Since the nomination of Dr. Scott Gottlieb to head the FDA, we’ve seen quite a few references to his opposition to the current FDA prohibition against off-label promotion – regardless of the truth of the promotion itself. We...more

Seventh Circuit Holds that FDAAA Does Not Affect Mensing/Bartlett Preemption

by Reed Smith on

When we first set foot on the University of Chicago Law School campus back in 1982, Chicago sports were a mess. But quickly – certainly more quickly than our ability to grasp the Rule in Shelley’s Case, Last Clear Chance, or...more

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

by K&L Gates LLP on

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

Product Liability Annual Review -- 2012

by Morrison & Foerster LLP on

In This Issue: Letter from Chair; Key Practice Highlights; Aviation; Consumer Products and Toxic Torts; Pharmaceutical Products and Medical Devices; Awards + Rankings; Publications; Key Contacts. Excerpt from...more

Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs

by Morrison & Foerster LLP on

Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11,...more

Stengel Tangles MDA Preemption: Ninth Circuit Decision Creates Split on Buckman Preemption of Post-Market Reporting Requirements

by Morrison & Foerster LLP on

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: “failure to warn the FDA.” The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S....more

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